External adjustment device for distraction device

ABSTRACT

An external adjustment device includes at least one permanent magnet configured for rotation about an axis with a first handle extending linearly at a first end of the device and a second handle at a second end of the device, the second handle extending in a direction substantially off axis to the first handle. The external adjustment device further includes a motor mounted inside the first handle and a first button located in the proximity to one of the first handle or the second handle, the first button configured to be operated by the thumb of a hand that grips the one of the first handle or second handle. The first button is configured to actuate the motor causing the at least one permanent magnet to rotate about the axis in a first direction.

RELATED APPLICATION

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

FIELD OF THE INVENTION

The field of the invention generally relates to medical devices fortreating disorders of the skeletal system.

BACKGROUND

Scoliosis is a general term for the sideways (lateral) curving of thespine, usually in the thoracic or thoracolumbar region. Scoliosis iscommonly broken up into different treatment groups, AdolescentIdiopathic Scoliosis, Early Onset Scoliosis and Adult Scoliosis.

Adolescent Idiopathic Scoliosis (AIS) typically affects children betweenages 10 and 16, and becomes most severe during growth spurts that occuras the body is developing. One to two percent of children between ages10 and 16 have some amount of scoliosis. Of every 1000 children, two tofive develop curves that are serious enough to require treatment. Thedegree of scoliosis is typically described by the Cobb angle, which isdetermined, usually from x-ray images, by taking the most tiltedvertebrae above and below the apex of the curved portion and measuringthe angle between intersecting lines drawn perpendicular to the top ofthe top vertebrae and the bottom of the bottom. The term idiopathicrefers to the fact that the exact cause of this curvature is unknown.Some have speculated that scoliosis occurs when, during rapid growthphases, the ligamentum flavum of the spine is too tight and hinderssymmetric growth of the spine. For example, as the anterior portion ofthe spine elongates faster than the posterior portion, the thoracicspine begins to straighten, until it curves laterally, often with anaccompanying rotation. In more severe cases, this rotation actuallycreates a noticeable deformity, wherein one shoulder is lower than theother. Currently, many school districts perform external visualassessment of spines, for example in all fifth grade students. For thosestudents in whom an “S” shape or “C” shape is identified, instead of an“I” shape, a recommendation is given to have the spine examined by aphysician, and commonly followed-up with periodic spinal x-rays.

Typically, patients with a Cobb angle of 20° or less are not treated,but are continually followed up, often with subsequent x-rays. Patientswith a Cobb angle of 40° or greater are usually recommended for fusionsurgery. It should be noted that many patients do not receive thisspinal assessment, for numerous reasons. Many school districts do notperform this assessment, and many children do not regularly visit aphysician, so often, the curve progresses rapidly and severely. There isa large population of grown adults with untreated scoliosis, in extremecases with a Cobb angle as high as or greater than 90°, Many of theseadults, though, do not have pain associated with this deformity, andlive relatively normal lives, though oftentimes with restricted mobilityand motion. In AIS, the ratio of females to males for curves under 10°is about one to one, however, at angles above 30°, females outnumbermales by as much as eight to one. Fusion surgery can be performed on theAIS patients or on adult scoliosis patients. In a typical posteriorfusion surgery, an incision is made down the length of the back andTitanium or stainless steel straightening rods are placed along thecurved portion. These rods are typically secured to the vertebralbodies, for example with hooks or bone screws, or more specificallypedicle screws, in a manner that allows the spine to be straightened.Usually, at the section desired for fusion, the intervertebral disks areremoved and bone graft material is placed to create the fusion. If thisis autologous material, the bone is harvested from a hip via a separateincision.

Alternatively, the fusion surgery may be performed anteriorly. A lateraland anterior incision is made for access. Usually, one of the lungs isdeflated in order to allow access to the spine from this anteriorapproach. In a less-invasive version of the anterior procedure, insteadof the single long incision, approximately five incisions, each aboutthree to four cm long are made in several of the intercostal spaces(between the ribs) on one side of the patient. In one version of thisminimally invasive surgery, tethers and bone screws are placed and aresecured to the vertebra on the anterior convex portion of the curve.Currently, clinical trials are being performed which use staples inplace of the tether/screw combination. One advantage of this surgery incomparison with the posterior approach is that the scars from theincisions are not as dramatic, though they are still located in avisible area, when a bathing suit, for example, is worn. The stapleshave had some difficulty in the clinical trials. The staples tend topull out of the bone when a critical stress level is reached.

In some cases, after surgery, the patient will wear a protective bracefor a few months as the fusing process occurs. Once the patient reachesspinal maturity, it is difficult to remove the rods and associatedhardware in a subsequent surgery, because the fusion of the vertebrausually incorporates the rods themselves. Standard practice is to leavethis implant in for life. With either of these two surgical methods,after fusion, the patient's spine is now straight, but depending on howmany vertebra were fused, there are often limitations in the degree offlexibility, both in bending and twisting. As these fused patientsmature, the fused section can impart large stresses on the adjacentnon-fused vertebra, and often, other problems including pain can occurin these areas, sometimes necessitating further surgery. This tends tobe in the lumbar portion of the spine that is prone to problems in agingpatients. Many physicians are now interested in fusionless surgery forscoliosis, which may be able to eliminate some of the drawbacks offusion.

One group of patients in which the spine is especially dynamic is thesubset known as Early Onset Scoliosis (EOS), which typically occurs inchildren before the age of five, and more often in boys than in girls.This is a more rare condition, occurring in only about one or two out of10,000 children, but can be severe, sometimes affecting the normaldevelopment of organs. Because of the fact that the spines of thesechildren will still grow a large amount after treatment, non-fusiondistraction devices known as growing rods and a device known as theVEPTR—Vertical Expandable Prosthetic Titanium Rib (“Titanium Rib”) havebeen developed. These devices are typically adjusted approximately everysix months, to match the child's growth, until the child is at leasteight years old, sometimes until they are 15 years old. Each adjustmentrequires a surgical incision to access the adjustable portion of thedevice. Because the patients may receive the device at an age as earlyas six months old, this treatment requires a large number of surgeries.Because of the multiple surgeries, these patients have a rather highpreponderance of infection.

Returning to the AIS patients, the treatment methodology for those witha Cobb angle between 20° and 40° is quite controversial. Many physiciansproscribe a brace (for example, the Boston Brace), that the patient mustwear on their body and under their clothes 18 to 23 hours a day untilthey become skeletally mature, for example to age 16. Because thesepatients are all passing through their socially demanding adolescentyears, it is quite a serious prospect to be forced with the choice ofeither wearing a somewhat bulky brace that covers most of the upperbody, having fusion surgery that may leave large scars and also limitmotion, or doing nothing and running the risk of becoming disfigured andpossibly disabled. It is commonly known that many patients have at timeshidden their braces, for example, in a bush outside of school, in orderto escape any related embarrassment. The patient compliance with bracewearing has been so problematic that there have been special bracesconstructed which sense the body of the patient, and keep track of theamount of time per day that the brace is worn. Patients have even beenknown to place objects into unworn braces of this type in order to foolthe sensor. Coupled with the inconsistent patient compliance with braceusage, is a feeling by many physicians that braces, even if usedproperly, are not at all effective at curing scoliosis. These physiciansmay agree that bracing can possibly slow down or even temporarily stopcurve (Cobb angle) progression, but they have noted that as soon as thetreatment period ends and the brace is no longer worn, often thescoliosis rapidly progresses, to a Cobb angle even more severe than itwas at the beginning of treatment. Some say the reason for the supposedineffectiveness of the brace is that it works only on a portion of thetorso, and not on the entire spine. Currently a prospective, randomized500 patient clinical trial known as BrAIST (Bracing in AdolescentIdiopathic Scoliosis Trial) is enrolling patients, 50% of whom will betreated with the brace and 50% of who will simply be watched. The Cobbangle data will be measured continually up until skeletal maturity, oruntil a Cobb angle of 50° is reached, at which time the patient willlikely undergo surgery. Many physicians feel that the BrAIST trial willshow that braces are completely ineffective. If this is the case, thequandary about what to do with AIS patients who have a Cobb angle ofbetween 20° and 40° will only become more pronounced. It should be notedthat the “20° to 40°” patient population is as much as ten times largerthan the “40° and greater” patient population.

Distraction osteogenesis, also known as distraction callotasis andosteodistraction has been used successfully to lengthen long bones ofthe body. Typically, the bone, if not already fractured, is purposelyfractured by means of a corticotomy, and the two segments of bone aregradually distracted apart, which allows new bone to form in the gap. Ifthe distraction rate is too high, there is a risk of nonunion, if therate is too low, there is a risk that the two segments will completelyfuse to each other before the distraction period is complete. When thedesired length of the bone is achieved using this process, the bone isallowed to consolidate. Distraction osteogenesis applications are mainlyfocused on the growth of the femur or tibia, but may also include thehumerus, the jaw bone (micrognathia), or other bones. The reasons forlengthening or growing bones are multifold, the applications including,but not limited to: post osteosarcoma bone cancer; cosmetic lengthening(both legs-femur and/or tibia) in short stature ordwarfism/achondroplasia; lengthening of one limb to match the other(congenital, post-trauma, post-skeletal disorder, prosthetic kneejoint), nonunions.

Distraction osteogenesis using external fixators has been done for manyyears, but the external fixator can be unwieldy for the patient. It canalso be painful, and the patient is subject to the risk of pin trackinfections, joint stiffness, loss of appetite, depression, cartilagedamage and other side effects. Having the external fixator in place alsodelays the beginning of rehabilitation.

In response to the shortcomings of external fixator distraction,intramedullary distraction nails have been surgically implanted whichare contained entirely within the bone. Some are automaticallylengthened via repeated rotation of the patient's limb. This cansometimes be painful to the patient, and can often proceed in anuncontrolled fashion. This therefore makes it difficult to follow thestrict daily or weekly lengthening regime that avoids nonunion (if toofast) or early consolidation (if too slow). Lower limb distraction ratesare on the order of one mm per day. Other intramedullary nails have beendeveloped which have an implanted motor and are remotely controlled byan antenna. These devices are therefore designed to be lengthened in acontrolled manner, but due to their complexity, may not bemanufacturable as an affordable product. Others have proposedintramedullary distractors containing and implanted magnet, which allowsthe distraction to be driven electromagnetically by an external stator.Because of the complexity and size of the external stator, thistechnology has not been reduced to a simple and cost-effective devicethat can be taken home, to allow patients to do daily lenthenings.

SUMMARY

In one embodiment, an external adjustment device includes at least onepermanent magnet configured for rotation about an axis. The externaladjustment device further includes a first handle extending linearly ata first end of the device and a second handle disposed at a second endof the device, the second handle extending in a direction that is angledrelative to the first handle. The external adjustment device includes amotor mounted inside the first handle and a first button located in theproximity to one of the first handle or the second handle, the firstbutton configured to be operated by the thumb of a hand that grips theone of the first handle or second handle. The first button is configuredto actuate the motor causing the at least one permanent magnet to rotateabout the axis in a first direction.

In another embodiment, an external adjustment device includes at leastone permanent magnet configured for rotation about an axis and a motorconfigured for rotating the at least one permanent magnet about theaxis. The external adjustment device includes a first handle extendinglinearly at a first end of the device and a second handle disposed at asecond end of the device, the second handle extending in a directionthat is substantially off axis with respect to the first handle, whereinone of the first and second handle comprises a looped shape. A firstdrive button is located in the proximity to one of the first handle orthe second handle, the first drive button configured to be operated bythe thumb of a hand that grips the one of the first handle or secondhandle. The first drive button is configured to actuate the motorcausing the at least one permanent magnet to rotate about the axis in afirst direction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an external adjustment device configured to operate adistraction device.

FIG. 2 illustrates a detailed view of the display and control panel ofthe external adjustment device.

FIG. 3 illustrates the lower or underside surfaces of the externaladjustment device.

FIG. 4 illustrates a sectional view of the external adjustment devicetaken along line 4-4 of FIG. 3.

FIG. 5 illustrates a sectional view of the external adjustment devicetaken along line 5-5 of FIG. 3.

FIG. 6 schematically illustrates the orientation of the magnets of theexternal adjustment device while driving an implanted magnet of adistraction device.

FIG. 7 illustrates various sensors connected to a printed circuit boardof the external adjustment device.

FIG. 8 illustrates a view of the clock positions of Hall effect sensorson the printed circuit board of the external adjustment device.

FIG. 9A illustrates a particular configuration of Hall effect sensorsaccording to one embodiment.

FIG. 9B illustrates output voltage of the Hall effect sensors of theconfiguration in FIG. 9A.

FIG. 9C illustrates the configuration of FIG. 9A, with the magnets in anonsynchronous condition.

FIG. 9D illustrates the output voltage of the Hall effect sensors of theconfiguration in FIG. 9C.

FIG. 10A illustrates a particular configuration of Hall effect sensorsaccording to another embodiment.

FIG. 10B illustrates the output voltage of the Hall effect sensors ofthe configuration in FIG. 10A.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIGS. 1-3 illustrate an external adjustment device 700 that isconfigured for adjusting a distraction device 1000. The distractiondevice 1000 may include any number of distraction devices such as thosedisclosed in U.S. patent application Ser. Nos. 12/121,355, 12/250,442,12/391,109, 11/172,678 which are incorporated by reference herein. Thedistraction device 1000 generally includes a rotationally mounted,internal permanent magnet 1010 that rotates in response to the magneticfield applied by the external adjustment device 700. Rotation of themagnet 1010 in one direction effectuates distraction while rotation ofthe magnet 1010 in the opposing direction effectuates retraction,external adjustment device 700 may be powered by a rechargeable batteryor by a power cord 711. The external adjustment device 700 includes afirst handle 702 and a second handle 704. The second handle 704 is in alooped shape, and can be used to carry the external adjustment device700. The second handle 704 can also be used to steady the externaladjustment device 700 during use. Generally, the first handle 702extends linearly from a first end of the external adjustment device 700while the second handle 704 is located at a second end of the externaladjustment device 700 and extends substantially off axis or is angledwith respect to the first handle 702. In one embodiment, the secondhandle 704 may be oriented substantially perpendicular relative to thefirst handle 702 although other

The first handle 702 contains the motor 705 that drives a first externalmagnet 706 and a second external magnet 708 as best seen in FIG. 3, viagearing, belts and the like. On the first handle 702 is an optionalorientation image 804 comprising a body outline 806 and an optionalorientation arrow 808 that shows the correct direction to place theexternal adjustment device 700 on the patient's body, so that thedistraction device is operated in the correct direction. While holdingthe first handle 702, the operator presses with his thumb thedistraction button 722, which has a distraction symbol 717, and is afirst color, for example green. This distracts the distraction device1000. If the distraction device 1000 is over-distracted and it isdesired to retract, or to lessen the distraction of the device 1000, theoperator presses with his thumb the retraction button 724 which has aretraction symbol 719.

Distraction turns the magnets 706, 708 one direction and retractionturns the magnets 706, 708 in the opposite direction. Magnets 706, 708have stripes 809 that can be seen in window 811. This allows easyidentification of whether the magnets 706, 708 are stationary orturning, and in which direction they are turning. This allows quicktrouble shooting by the operator of the device. The operator candetermine the point on the patient where the magnet of the distractiondevice 1000 is implanted, and can then put the external adjustmentdevice 700 in correct location with respect to the distraction device1000, by marking the corresponding portion of the skin of the patient,and then viewing this spot through the alignment window 716 of theexternal adjustment device 700.

A control panel 812 includes several buttons 814, 816, 818, 820 and adisplay 715. The buttons 814, 816, 818, 820 are soft keys, and able tobe programmed for an array of different functions. In one configuration,the buttons 814, 816, 818, 820 have corresponding legends which appearin the display. To set the length of distraction to be performed on thedistraction device 1000, the target distraction length 830 is adjustedusing an increase button 814 and a decrease button 816. The legend witha green plus sign graphic 822 corresponds to the increase button 814 andthe legend with a red negative sign graphic 824 corresponds to thedecrease button 816. It should be understood that mention herein to aspecific color used for a particular feature should be viewed asillustrative. Other colors besides those specifically recited herein maybe used in connection with the inventive concepts described herein. Eachtime the increase button 814 is depressed, it causes the targetdistraction length 830 to increase 0.1 mm. Each time the decrease button816 is depressed it causes the target distraction length 830 to decrease0.1 mm. Of course, other decrements besides 0.1 mm could also be used.When the desired target distraction length 830 is displayed, and theexternal adjustment device 700 is correctly placed on the patient, theoperator then holds down the distraction button 722 and the ExternalDistraction Device 700 operates, turning the magnets 706, 708, until thetarget distraction length 830 is achieved. Following this, the externaladjustment device 700 stops. During the distraction process, the actualdistraction length 832 is displayed, starting at 0.0 mm and increasinguntil the target distraction length 830 is achieved. As the actualdistraction length 832 increases, a distraction progress graphic 834 isdisplayed. For example a light colored box 833 that fills with a darkcolor from the left to the right. In FIG. 2, the target distractionlength 830 is 3.5 mm, and 2.1 mm of distraction has occurred, 60% of thebox 833 of the distraction progress graphic 834 is displayed. A resetbutton 818 corresponding to a reset graphic 826 can be pressed to resetone or both of the numbers back to zero. An additional button 820 can beassigned for other functions (help, data, etc.). This button can haveits own corresponding graphic 828. Alternatively, a touch screen can beused, for example capacitive or resistive touch keys. In thisembodiment, the graphics/legends 822, 824, 826, 828 may also be touchkeys, replacing or augmenting the buttons 814, 816, 818, 820. In oneparticular embodiment, touch keys at 822, 824, 826, 828 perform thefunctions of buttons 814, 816, 818, 820 respectively, and the buttons814, 816, 818, 820 are eliminated.

The two handles 702, 704 can be held in several ways. For example thefirst handle 702 can be held with palm facing up while trying to findthe location on the patient of the implanted magnet of the distractiondevice 1000. The fingers are wrapped around the handle 702 and thefingertips or mid-points of the four fingers press up slightly on thehandle 702, balancing it somewhat. This allows a very sensitive feelthat allows the magnetic field between the magnet in the distractiondevice 1000 and the magnets 706, 708 of the external adjustment device700 to be more obvious, During the distraction of the patient, the firsthandle 702 may be held with the palm facing down, allowing the operatorto push the device down firmly onto the patient, to minimize thedistance between the magnets 706, 708 of the external adjustment deviceand the magnet 1010 of the distraction device 1000, thus maximizing thetorque coupling. This is especially appropriate if the patient is largeor somewhat obese. The second handle 704 may be held with the palm up orthe palm down during the magnet sensing operation and the distractionoperation, depending on the preference of the operator.

FIG. 3 illustrates the underside or lower surface of the externaladjustment device 700. At the bottom of the external adjustment device700, the contact surface 836 may be made of material of a softdurometer, such as elastomeric material, for example PEBAX® orPolyurethane. This allows for anti-shock to protect the device 700 if itis dropped. Also, if placing the device on patient's bare skin,materials of this nature do not pull heat away from patient as quickly,and so they “don't feel as cold” as hard plastic or metal. The handles702, 704 may also have similar material covering them, in order to actas non-slip grips.

FIG. 3 also illustrates child friendly graphics 837, including theoption of a smiley face. Alternatively this could be an animal face,such as a teddy bear, a horsey or a bunny rabbit. A set of multiplefaces can be removable and interchangeable to match the likes of variousyoung patients. In addition, the location of the faces on the undersideof the device, allows the operator to show the faces to a younger child,but keep it hidden from an older child, who may not be so amused.Alternatively, sock puppets or decorative covers featuring human, animalor other characters may be produced so that the device may be thinlycovered with them, without affecting the operation of the device, butadditionally, the puppets or covers may be given to the young patientafter a distraction procedure is performed. It is expected that this canhelp keep a young child more interested in returning to futureprocedures.

FIGS. 4 and 5 are sectional views that illustrate the internalcomponents of the external adjustment device 700 taken along variouscenterlines. FIG. 4 is a sectional view of the external adjustmentdevice 700 taken along the line 4-4 of FIG. 3. FIG. 5 is a sectionalview of the external adjustment device 700 taken along the line 5-5 ofFIG. 3. The external adjustment device 700 comprises a first housing868, a second housing 838 and a central magnet section 725. First handle702 and second handle 704 include grip 703 (shown on first handle 702).Grip 703 may be made of an elastomeric material and may have a soft feelwhen gripped by the hand. The material may also have a tacky feel, inorder to aid firm gripping. Power is supplied via power cord 711, whichis held to second housing 838 with a strain relief 844. Wires 727connect various electronic components including motor 840 which rotatesmagnets 706, 708 via gear box 842, output gear 848, center gear 870respectively, center gear 870 rotating two magnet gears 852, one on eachmagnet 706, 708 (one such gear 852 is illustrated in FIG. 5). Outputgear 848 is attached to motor output via coupling 850, and both motor840 and output gear 848 are secured to second housing 838 via mount 846.Magnets 706, 708 are held within magnet cups 862. Magnets and gears areattached to bearings 872, 874, 856, 858, which aid in low frictionrotation. Motor 840 is controlled by motor printed circuit board (PCB)854, while the display is controlled by display printed circuit board(PCB) 866 (FIG. 4). Display PCB 866 is attached to frame 864.

FIG. 6 illustrates the orientation of poles of the first and secondexternal magnets 706, 708 and the implanted magnet 1010 of thedistraction device 1000 during a distraction procedure. For the sake ofdescription, the orientations will be described in relation to thenumbers on a clock. First external magnet 706 is turned (by gearing,belts, etc.) synchronously with second external magnet 708 so that northpole 902 of first external magnet 706 is pointing in the twelve o'clockposition when the south pole 904 of the second external magnet 708 ispointing in the twelve o'clock position. At this orientation, therefore,the south pole 906 of the first external magnet 706 is pointing ispointing in the six o'clock position while the north pole 908 of thesecond external magnet 708 is pointing in the six o'clock position. Bothfirst external magnet 706 and second external magnet 708 are turned in afirst direction as illustrated by respective arrows 914, 916. Therotating magnetic fields apply a torque on the implanted magnet 1010,causing it to rotate in a second direction as illustrated by arrow 918.Exemplary orientation of the north pole 1012 and south pole 1014 of theimplanted magnet 1010 during torque delivery are shown in FIG. 6. Whenthe first and second external magnets 706, 708 are turned in theopposite direction from that shown, the implanted magnet 1010 will beturned in the opposite direction from that shown. The orientation of thefirst external magnet 706 and the second external magnet 708 in relationto each other serves to optimize the torque delivery to the implantedmagnet 1010. During operation of the external adjustment device 700, itis often difficult to confirm that the two external magnets 706, 708 arebeing synchronously driven as desired. Turning to FIGS. 7 and 8, inorder to ensure that the external adjustment device 700 is workingproperly, the motor printed circuit board 854 comprises one or moreencoder systems, for example photointerrupters 920, 922 and/or Halleffect sensors 924, 926, 928, 930, 932, 934, 936, 938. Photointerrupters920, 922 each comprise an emitter and a detector. A radially stripedring 940 may be attached to one or both of the external magnets 706, 708allowing the photointerrupters to optically encode angular motion. Light921, 923 is schematically illustrated between the radially striped ring940 and photointerrupters 920, 922.

Independently, Hall effect sensors 924, 926, 928, 930, 932, 934, 936,938 may be used as non-optical encoders to track rotation of one or bothof the external magnets 706, 708. While eight (8) such Hall effectsensors are illustrated in FIG. 7 it should be understood that fewer ormore such sensors may be employed. The Hall effect sensors are connectedto the motor printed circuit board 854 at locations that allow the Halleffect sensors to sense the magnetic field changes as the externalmagnets 706, 708 rotate. Each Hall effect sensor 924, 926, 928, 930,932, 934, 936, 938 outputs a voltage that corresponds to increases ordecreases in the magnetic field. FIG. 9A indicates one basic arrangementof Hall effect sensors relative to sensors 924, 938. A first Hall effectsensor 924 is located at nine o'clock in relation to first externalmagnet 706. A second Hall effect sensor 938 is located at three o'clockin relation to second external magnet 708. As the magnets 706, 708rotate correctly in synchronous motion, the first voltage output 940 offirst Hall effect sensor 924 and second voltage output 942 of secondHall effect sensor have the same pattern, as seen in FIG. 9B, whichgraphs voltage for a full rotation cycle of the external magnets 706,708. The graph indicates a sinusoidal variance of the output voltage,but the clipped peaks are due to saturation of the signal. Even if Halleffect sensors used in the design cause this effect, there is stillenough signal to compare the first voltage output 940 and the secondvoltage output 942 over time. If either of the two Hall effect sensors924, 938 does not output a sinusoidal signal during the operation or theexternal adjustment device 700, this demonstrates that the correspondingexternal magnet has stopped rotating, for example due to adhesivefailure, gear disengagement, etc. FIG. 9C illustrates a condition inwhich both the external magnets 706, 708 are rotating at the sameapproximate angular speed, but the north poles 902, 908 are notcorrectly synchronized. Because of this, the first voltage output 940and second voltage output 942 are now out-of-phase, and exhibit a phaseshift (e). These signals are processed by a processor 915 and an errorwarning is displayed on the display 715 of the external adjustmentdevice 700 so that the device may be resynchronized.

If independent stepper motors are used, the resynchronization processmay simply be one of reprogramming, but if the two external magnets 706,708 are coupled together, by gearing or belt for example, then amechanical rework may be required. An alternative to the Hall effectsensor configuration of FIG. 9A is illustrated in FIG. 10A. In thisembodiment, a third Hall effect sensor 928 is located at twelve o'clockin relation to the first external magnet 706 and a fourth Hall effectsensor 934 is located at twelve o'clock in relation to the secondexternal magnet 708. With this configuration, the north pole 902 of thefirst external magnet 706 should be pointing towards the third Halleffect sensor 928 when the south pole 904 of the second external magnet708 is pointing towards the fourth Hall effect sensor 934. With thisarrangement, the third Hall effect sensor 928 outputs a third outputvoltage 944 and the fourth Hall effect sensor 934 outputs a fourthoutput voltage 946 (FIG. 0.10B). The third output voltage 944 is bydesign out of phase with the fourth output voltage 946. An advantage ofthe Hall effect sensor configuration of FIG. 9A is that the each sensorhas a larger distance between it and the opposite magnet, for examplefirst Hall effect sensor 924 in comparison to second external magnet708, so that there is less possibility of interference. An advantage tothe Hall effect sensor configuration of FIG. 10A is that it may bepossible to make a more compact external adjustment device 700 (lesswidth). The out-of-phase pattern of FIG. 10B can also be analyzed toconfirm magnet synchronicity.

Returning to FIGS. 7 and 8, additional Hall effect sensors 926, 930,932, 936 are shown. These additional sensors allow additional precisionto the rotation angle feedback of the external magnets 706, 708 of theexternal adjustment device 700. Again, the particular number andorientation of Hall effect sensors may vary. In place of the Hall effectsensors, magnetoresistive encoders may also be used.

In still another embodiment, additional information may be processed byprocessor 915 and may be displayed on display 715. For example,distractions using the external adjustment device 700 may be performedin a doctor's office by medical personnel, or by patients or members ofpatient's family in the home. In either case, it may be desirable tostore information from each distraction session that can be accessedlater. For example, the exact date and time of each distraction, and theamount of distraction attempted and the amount of distraction obtained.This information may be stored in the processor 915 or in one or morememory modules (not shown) associated with the processor 915. Inaddition, the physician may be able to input distraction length limits,for example the maximum amount that can be distracted at each session,the maximum amount per day, the maximum amount per week, etc. Thephysician may input these limits by using a secure entry using the keysor buttons of the device, that the patient will not be able to access.

Returning to FIG. 1, in some patients, it may be desired to place afirst end 1018 of the distraction device 1000 proximally in the patient,or towards the head, and second end 1020 of the distraction device 1000distally, or towards the feet. This orientation of the distractiondevice 1000 may be termed antegrade. In other patients, it may bedesired to orient the distraction device 1000 with the second end 1020proximally in the patient and the first end 1018 distally. In this case,the orientation of the distraction device 1000 may be termed retrograde.In a distraction device 1000 in which the magnet 1010 rotates in orderto turn a screw within a nut, the orientation of the distraction device1000 being either antegrade or retrograde in patient could mean that theexternal adjustment device 700 would have to be placed in accordancewith the orientation image 804 when the distraction device 1000 isplaced antegrade, but placed the opposite of the orientation image 804when the distraction device 1000 is placed retrograde. Alternatively,software may be programmed so that the processor 915 recognizes whetherthe distraction device 1000 has been implanted antegrade or retrograde,and then turns the magnets 706, 708 in the appropriate direction whenthe distraction button 722 is placed.

For example, the motor 705 would be commanded to rotate the magnets 706,708 in a first direction when distracting an antegrade placeddistraction device 1000, and in a second, opposite direction whendistracting a retrograde placed distraction device 1000. The physicianmay, for example, be prompted by the display 715 to input using thecontrol panel 812 whether the distraction device 1000 was placedantegrade or retrograde. The patient may then continue to use the sameexternal adjustment device 700 to assure that the motor 705 turns themagnets 706, 708 in the proper directions for both distraction andretraction. Alternatively, the distraction device may incorporate anRFID chip 1022 which can be read and written to by an antenna 1024 onthe external adjustment device 700. The position of the distractiondevice 1000 in the patient (antegrade or retrograde) is written to theRFID chip 1022, and can thus be read by the antenna 1024 of any externaladjustment device 700, allowing the patient to get correct distractionsor retractions, regardless of which external adjustment device 700 isused.

While embodiments have been shown and described, various modificationsmay be made without departing from the scope of the inventive conceptsdisclosed herein. The invention(s), therefore, should not be limited,except to the following claims, and their equivalents.

What is claimed is:
 1. An external adjustment device comprising: atleast one permanent magnet configured for rotation about an axis; afirst handle extending linearly at a first end of the device; a secondhandle disposed at a second end of the device, the second handleextending in a direction that is angled relative to the first handle; amotor mounted inside the first handle; a first button located in theproximity to one of the first handle or the second handle, the firstbutton configured to be operated by the thumb of a hand that grips theone of the first handle or second handle; wherein the first button isconfigured to actuate the motor causing the at least one permanentmagnet to rotate about the axis in a first direction.
 2. The externaladjustment device of claim 1, further comprising a second button locatedin proximity to the first button, the second button configured toactuate the motor causing the at least one permanent magnet to rotateabout the axis in a second direction.
 3. The external adjustment deviceof claim 1, further comprising a control panel having a plurality ofbuttons and a display.
 4. The external adjustment device of claim 3,wherein the plurality of buttons comprise a target distraction increasebutton and a target distraction decrease button.
 5. The externaladjustment device of claim 1, wherein the at least one permanent magnetis rotatably disposed in a housing having a window therein and whereinthe at least one permanent magnet contains a plurality of stripesvisible via the window.
 6. The external adjustment device of claim 1,wherein the at least one permanent magnet comprises two permanentmagnets.
 7. The external adjustment device of claim 1, furthercomprising an orientation image on the first handle.
 8. The externaladjustment device of claim 1, wherein one of the first handle or secondhandle comprises a looped shape.
 9. The external adjustment device ofclaim 3, wherein the plurality of buttons comprises at least one touchkey.
 10. The external adjustment device of claim 1, further comprisingat least one magnetic sensor configured to sense a change in a magneticfield of the at least one permanent magnet and to output a voltage basedat least partially on strength of the magnetic field.
 11. An externaladjustment device comprising: at least one permanent magnet configuredfor rotation about an axis; a motor configured for rotating the at leastone permanent magnet about the axis; a first handle extending linearlyat a first end of the device; a second handle disposed at a second endof the device, the second handle extending in a direction that issubstantially off axis with respect to the first handle, wherein one ofthe first and second handle comprises a looped shape; a first drivebutton located in the proximity to one of the first handle or the secondhandle, the first drive button configured to be operated by the thumb ofa hand that grips the one of the first handle or second handle; andwherein the first drive button is configured to actuate the motorcausing the at least one permanent magnet to rotate about the axis in afirst direction.
 12. The external adjustment device of claim 11, furthercomprising at least one magnetic sensor configured to sense a change ina magnetic field of the at least one permanent magnet and output avoltage based at least in part on a strength of the magnetic field. 13.The external adjustment device of claim 12, further comprising a secondmagnetic sensor configured to sense a change in a magnetic field of theat least one permanent magnet and output a voltage based at least inpart on a strength of the magnetic field.
 14. The external adjustmentdevice of claim 13, further comprising a processor configured to comparerespective output voltages from the first and second magnetic sensors.15. The external adjustment device of claim 13, further comprising asecond button located in proximity to the first button, the secondbutton configured to actuate the motor causing the at least onepermanent magnet to rotate about the axis in a second direction.
 16. Theexternal adjustment device of claim 11, further comprising: adistraction device configured for implantation within a subject; and aprocessor disposed in the external adjustment device and configured toactuate the motor causing the at least one permanent magnet to rotateabout the axis in a first direction when the distraction device isimplanted an antegrade orientation and in a second direction when thedistraction device is implanted in a retrograde orientation.
 17. Theexternal adjustment device of claim 16, further comprising a read/writeRFID chip disposed on the distraction device.
 18. The externaladjustment device of claim 17, wherein the external adjustment devicecomprises an antenna configured to receive and transmit data to theread/write RFID chip.
 19. The external adjustment device of claim 18,wherein the data comprises the orientation of the distraction device.20. The external adjustment device of claim 16, wherein the processor isconfigured to receive instructions from a user as the antegrade orretrograde orientation of the distraction device.